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Arcutis Biotherapeutics
NEWS

Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis

Shots: FDA approved Zoryve (0.05% roflumilast; QD) for pts (2-5yrs.) based on P-III (INTEGUMENT-PED), INTEGUMENT-OLE study & a P-I PK trial; commercially available by end of Oct 2025 INTEGUMENT-PED (n=652) showed rapid disease clearance with benefits from Wk. 1, as 25.4% vs 10.7% achieved vIGA-AD Success & a 2-grade improvement at Wk. 4; trial also met all…
October 7, 2025

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Abbvie
NEWS

AbbVie Reports Topline P-II (ELATE) Trial Data on Botox (OnabotulinumtoxinA) for Upper Limb Essential Tremor

Shots: AbbVie has reported topline P-II (ELATE) trial data assessing Botox (onabotulinumtoxinA) vs PBO in pts with upper limb essential tremor Trial met its 1EP with improved Tremor Disability Scale-Revised scores at 18wks. & showed a greater TREDS-R total unilateral score reduction (-2.61 vs -1.61), plus it also achieved all six 2EPs; data to be…
October 7, 2025

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Astrazeneca
NEWS

AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension

Shots: AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks. Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…
October 7, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancer sNDA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157), which showed improved PFS by 44%,…
October 7, 2025

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NEWS

Algen Biotechnologies Collaborates with AstraZeneca to Advance Drug Discovery in Immunology

Shots: Algen has entered into a multi-target collaboration with AstraZeneca to accelerate novel immunology target discovery, leveraging the AlgenBrain platform As per the deal, AstraZeneca will receive exclusive rights to develop and commercialize therapies for selected targets identified through the partnership in exchange for ~555M incl. upfront, development, regulatory & commercial milestone payments  AlgenBrain models disease…
October 7, 2025

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NEWS

Chiesi Group Enters a ~$2.1B Deal with Arbor Biotechnologies to Develop Novel Rare Disease Gene Editing Programs

Shots: Chiesi Group has entered into an exclusive global collaboration & license deal with Arbor for ABO-101 in primary hyperoxaluria type 1 (PH1) & a multitarget option to use Arbor’s gene editing platform for developing liver-targeted therapies for rare diseases As per the deal, Chiesi will obtain exclusive rights to develop & commercialize ABO-101 for PH1…
October 7, 2025

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NEWS

IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer

Shots: The US FDA granted De Novo marketing authorization to ProSense cryoablation system for treating women (≥70yrs.) with biologically low-risk breast tumors (≤1.5cm) on adjuvant endocrine therapy ProSense is a minimally invasive cryosurgical tool that uses liquid nitrogen to freeze & destroy tumors in breast, kidney, lung & liver, with similar safety & efficacy observed…
October 6, 2025

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Astrazeneca and Daiichi-Sankyo New
NEWS

AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer

Shots: The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an option Trial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data to be presented in a future meeting &…
October 6, 2025

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NEWS

Roche and KlinRisk Secure CE Mark for Kidney Klinrisk Algorithm and Unveil CKD Algorithm Panel

Shots: Roche & KlinRisk have received CE-mark approval for the AI-based Kidney Klinrisk Algorithm to assess progressive kidney function decline, integrated into the navify Algorithm Suite The chronic kidney disease algorithm panel combines the new Klinrisk Algorithm for early risk assessment with the CE-marked KFRE Algorithm for later disease stages, supporting care across the full…
October 6, 2025

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